The present invention relates, in general, to collapsible medical fluid containers and, in particular, to such containers with two or more sealed compartments or chambers in which separate quantities of medical fluids or dry drugs or reagents may be stored for later intermixing and/or dispensing.
There are a number of medical fluids that are made by combining ingredients which, over the passage of time, react or are otherwise incompatible, resulting in unacceptable product degradation, or reduced efficacy. With such fluids, it is desirable to delay final preparation, such as mixing of the ingredients or components, until shortly prior to administration to the patient.
One example is a nutritional parenteral solution made by combining amino acid and dextrose. If there is a delay of many weeks or months between mixture of the ingredients and administration to the patient, a reaction between the ingredients results in unacceptable discoloration of fluid. Another example is the combination of heparin and dextrose. Dextrose has a relatively low pH compared to heparin. With the passage of time after mixing, the more acidic dextrose reduces the effectiveness of the heparin.
The reduced shelf life of these types of medical fluids, due to the reaction or incompatibility, has made large scale production impractical, and it has been the practice for hospital or clinical pharmacies to purchase separate containers of the particular components or ingredients and prepare the finished solution as required. This, of course, requires a relatively time consuming and inefficient transfer of fluid between the containers or into a third container. More importantly, however, the removal of one of the components from its original container carries with it the risk of impairing the sterility of the product.
In another example, it is also useful for dry or encapsulated drugs needing to be reconstituted or diluted prior to administration. The present invention allows the dry drug to be placed in one compartment and a diluent, such as sterile water, or liquid reagent in the other. The two may then be mixed or reconstituted by the means detailed in the application. This provides a sterile self-enclosed environment in which the mixing may take place and provides a more convenient means for maintaining and handling the drug and its appropriate fluid diluent or reagent prior to mixing. By providing controlled drug dosages and specific fluid amounts, it also prevents incorrect mixing or excessive dilution by an administrator.
One container which has been used for packaging of medical fluids in separate compartments is manufactured by Vifor, S.A., a Swiss corporation. It employs a pair of peripherally sealed plastic sheets with an intermediate seal line between the sheets dividing the container into a pair of compartments. An access port between the compartments is normally sealed with a break-apart closure that can be opened from the exterior of the container to permit mixing of the contents without breaking the sterility of the container. The port is opened by gripping an elongated portion of the closure through the plastic sheets and bending it until it breaks. There was a risk, however, with this procedure that the elongated portion may puncture the wall of the container causing leakage as well as a breach of sterility.
In addition to the needs of the medical industry with respect to the types of products and containers discussed above, there is often occasion for the physician to prescribe the periodic administration of a drug or other medical fluid. Such treatment typically requires the nurse or doctor repeatedly to obtain the unit dosage of the particular drug or fluid from the pharmacy and to administer it via syringe either directly into the patient or through an access site in an existing parenteral administration set which is already attached to the patient. In either case, these steps entail additional procedures and routines in the already busy day of most nurses and physicians.
Accordingly, it is a general object of the present invention to provide a medical fluid container for containing two or more medical fluids, or a dry drug or reagent and a diluent or liquid reagent in separate sealed relationship and providing for convenient and sterile intermixing just prior to administration and/or for periodic administration of unit dose quantities.
It is a further object of the present invention to provide such a container which may be opened without risk of puncturing the container wall.
It is another object of the present invention to provide an alternative construction for a multi-compartment container for containing two or more medical fluids or dry drugs and liquid agents in separate sealed relationships.